Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 099 | |||
| 2009_697 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | A-B-C-C |
|
| Treatment Sequence 2 | Experimental | B-C-A-C |
|
| Treatment Sequence 3 | Experimental | C-A-B-C |
|
| Treatment Sequence 4 | Experimental | A-C-B-C |
|
| Treatment Sequence 5 | Experimental | B-A-C-C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Treatment A | Other | No Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) | 0-160 minutes after start of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences | 11 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment Sequence 6 | Experimental | C-B-A-C |
|
| Comparator: Treatment B | Drug | single dose administration of exenatide 5ug by subcutaneous injection |
|
| Comparator: Treatment C | Drug | single dose administration of exenatide 10ug by subcutaneous injection |
|
| Comparator: graded glucose infusion | Procedure | A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods. |
|